Statement of Principles concerning Hashimoto thyroiditis (Reasonable Hypothesis) (No. 1 of 2022)

The central concept is the “reasonable hypothesis” standard, imported from section 120A of the VEA. The SoP does not require proof on the balance of probabilities; it merely identifies factors that, if present and related to service, will allow a hypothesis to be deemed reasonable in the absence of contrary proof. This is a lower threshold than normal civil causation, but the RMA has stated (in the body) that it is of the view that there is “sound medical‑scientific evidence” that Hashimoto thyroiditis and death from it can be related to relevant service. The instrument defines Hashimoto thyroiditis as a chronic, inflammatory, autoimmune disease of the thyroid characterised by lymphocytic infiltration and fibrosis and high titres of anti‑TPO or anti‑Tg antibodies. It explicitly excludes Graves disease, non‑autoimmune chronic thyroiditis, postpartum thyroiditis (which is a separate factor later), secondary hypothyroidism, and subacute thyroiditis. The definition covers goitrous, atrophic, and transient thyrotoxicosis variants. The instrument also defines “death from Hashimoto thyroiditis” to include death from a terminal event (pneumonia, respiratory failure, cardiac arrest, circulatory failure, cessation of brain function) contributed to by the disease.
“Relevant service” is defined in the dictionary and picks up six categories: operational, peacekeeping, hazardous, and British nuclear test defence service under the VEA, plus warlike and non‑warlike service under the MRCA. The factors themselves are mostly medical exposure events: iodine excess (defined by daily intake or urinary concentration), taking certain drugs (two separate Specified Lists), therapeutic radiation, radioactive iodine treatment, hepatitis C infection, obesity (BMI of 30 or more for at least 5 years), cessation of a regular smoking habit, postpartum thyroiditis, posttraumatic stress disorder, an acute precipitating event for myxoedema coma (a severe hypothyroid crisis), and pregnancy or postpartum state for worsening. Each factor has a specific time window, measured from “clinical onset” or “clinical worsening”. For example, iodine excess must occur within the six months before onset. Drug exposure must be within one year before onset for List 1 drugs, or continuous for at least two weeks within one year before worsening for List 2 drugs. The dictionaries for Specified List 1 and Specified List 2 are exhaustive: List 1 contains nine drugs (dasatinib, imatinib, interferon alpha, interferon beta, interleukin‑2, nilotinib, nivolumab, pembrolizumab, sunitinib); List 2 contains these nine plus amiodarone and lithium (total eleven). The inclusion of amiodarone and lithium only in the worsening list (not the onset list) reflects a deliberate distinction in medical evidence accepted by the RMA.

The instrument directly affects any person who has rendered “relevant service” and who makes a claim for a disability pension, compensation, or other benefit under the VEA or the MRCA where the claimed condition is Hashimoto thyroiditis. This includes Australian Defence Force members (including reserves), peacekeepers, and persons covered by British nuclear test defence service. The instrument does not apply to civilian claims, workers’ compensation, or private health insurance; its jurisdiction is strictly veterans’ entitlements. The SoP also indirectly affects the Repatriation Commission and the Department of Veterans’ Affairs (DVA) as the administering body that must assess claims. Medical practitioners who provide expert opinions in support of claims are affected because they must frame their reports around the factors listed in section 9. Legal practitioners representing veterans must know the SoP to construct legally plausible hypotheses. The RMA itself is affected as the rule‑maker that must update these instruments when medical evidence changes. Compliance professionals in the veterans’ advocacy sector (e.g. returned service organisations) will rely on the SoP to guide their casework. Importantly, the instrument does not impose duties or rights on private sector businesses directly, but it does create a market for medical evidence (e.g. endocrinologists, radiologists, pathologists) who may be engaged to prove factors such as iodine excess, hepatitis C infection, or drug exposure. The compliance burden falls on the claimant to produce evidence that the factor exists and is related to service. For example, proving iodine excess under the definition requires showing an average daily intake above 1,100 micrograms for adults (or 900 for those 18 and under) over a continuous three‑month period, or a urinary iodine concentration above 300 micrograms per litre. This may require food diaries, dietary supplements records, or laboratory results, all of which impose a search cost on the claimant. Similarly, proving obesity (BMI ≥30 for five years) demands historical weight records or medical records going back half a decade. The instrument thus affects the cost and feasibility of mounting a claim.

The SoP does not create new duties or rights in the private law sense. Its key legal function is to set out the evidentiary framework that the decision‑maker must apply when determining whether a reasonable hypothesis exists. The duty on the decision‑maker (the Commission, the Board, or the Tribunal) is to accept a hypothesis as reasonable if at least one factor in section 9 is present and that factor is related to the person’s relevant service (section 10(1)). Conversely, if no factor exists, the decision‑maker must find that the disease is not service‑related, subject to any other applicable SoP that might be incorporated via section 11. The claimant has a right to have their claim assessed according to this instrument, and cannot be prejudiced by the application of an older, superseded SoP (the 2013 version is repealed).
The instrument imposes an implicit duty on the claimant to present evidence substantiating one of the 22 factors. This is not a statutory duty, but a practical one: without such evidence, the claim will fail. The factor concerning “inability to obtain appropriate clinical management” (section 9(22)) creates a safety net: if no other factor applies, the disease may still be connected to service if the person could not obtain proper treatment. However, this factor must also be related to service. For example, a veteran posted to a remote area without access to endocrinology might argue this, but the instrument does not define “appropriate clinical management”, leaving room for dispute.
The instrument also creates a right to rely on other SoPs through section 11: if a factor (e.g. hepatitis C infection) is itself the subject of a separate SoP, then the factors of that SoP apply. This prevents duplication and ensures consistency. For example, if a claimant has hepatitis C acquired during service, they must satisfy the hepatitis C SoP to use factor 9(5) in this SoP.
The dictionary definitions are legally binding. For instance, “regular smoking habit as specified” is defined as at least 3 pack‑years within a continuous 3‑year period; a pack‑year is 20 cigarettes per day for one year or equivalent. This means that a person who smoked 10 cigarettes per day for 6 years (3 pack‑years over 6 years, but not continuous three years) may not satisfy the definition. This narrowness can affect the utility of the smoking cessation factor (9(7) and 9(17)).

This instrument contains no penalty provisions. It is not a regulatory or criminal law. Enforcement is therefore limited to the administrative process of claim determination. If a claimant or their representative fabricates evidence to satisfy a factor, that would be a matter for the general criminal law (e.g. fraud under the Criminal Code), but the SoP itself does not create any specific offence. The real “enforcement” mechanism is the refusal of a claim: if the decision‑maker concludes that none of the factors exist, the claim is denied, and the claimant bears the cost of unsuccessful litigation. There is no penalty for making a claim that fails; only the opportunity cost of time and legal fees.
The RMA itself is not an enforcement body. It is a statutory authority that determines SoPs based on medical‑scientific evidence. The instrument does not include a review or appeals mechanism; that is handled by the VEA and MRCA separately. However, the instrument could be challenged in judicial review proceedings (e.g. on grounds of ultra vires if the RMA exceeded its power under section 196B(2)). The test under section 196B(2) is whether the RMA is satisfied that there is “sound medical‑scientific evidence” that the disease can be related to service. An applicant might argue that the RMA acted on no evidence or made an irrational distinction (e.g. including amiodarone only in List 2 for worsening but not in List 1 for onset). But such arguments would need to overcome the high threshold for judicial review of legislative instruments.
The instrument also does not provide for compliance audits, fines, or reporting obligations. Its effect is purely evidentiary. The only “enforcement” risk is for the decision‑maker who fails to apply the SoP correctly: that could be a ground of appeal. But again, the SoP itself does not impose a duty on the decision‑maker; that duty arises from the enabling Acts.

The SoP is made under the VEA, specifically subsection 196B(2). It interacts directly with sections 120 and 120A of the VEA, and section 338 of the MRCA. Section 120A provides that for claims relating to operational service, the Commission must determine matters “to its reasonable satisfaction” but that a hypothesis is not reasonable unless it is upheld by the SoP. The SoP thus overrides any common‑law or medical opinion that does not fit within its factor framework. If a medical expert opines that there is a plausible connection based on a theory not listed (e.g. stress‑induced autoimmunity without PTSD), that opinion cannot sustain a reasonable hypothesis unless it matches one of the 22 factors. The SoP also interacts with other SoPs: section 11 of this instrument states that if a factor refers to a disease covered by another SoP, that other SoP applies. For example, factor 9(5) refers to infection with hepatitis C virus. If a person had hepatitis C from service, the decision‑maker must apply the hepatitis C SoP (if one exists) to determine whether that infection itself is service‑related. This prevents double‑counting and ensures consistency.
The instrument also interacts with the Repatriation Medical Authority Act 1986 (the RMA’s constituting Act), but that Act is not cited. The definitions of “VEA” and “MRCA” explicitly tie the SoP to those regimes. It does not interact with workers’ compensation laws, state health laws, or the Therapeutic Goods Act. It does not affect the legal status of Hashimoto thyroiditis under the National Health Act or the Pharmaceutical Benefits Scheme.
One notable interaction is with the Social Security Act 1991: a veteran who receives a disability pension based on this SoP may have that pension counted as income for other means‑tested benefits, but the SoP itself does not govern that.
The instrument also replaces the prior SoP (No. 31 of 2013), so any claim determined after 31 January 2022 must be assessed under the new instrument. Old claims that are not yet finalised may also be remitted for reconsideration if the new instrument is more favourable, but the VEA’s transitional provisions would govern that. The SoP does not have retrospective effect of its own force; it applies to claims to which section 120A or section 338 apply, which are claims made after commencement, or pending claims that have not been finally determined.

The instrument itself is a complete replacement. It explicitly repeals the Statement of Principles concerning Hashimoto’s thyroiditis No. 31 of 2013. No amendment history is provided within the instrument, but the 2013 version would have been the preceding instrument. The RMA occasionally issues amending instruments, but this is a new determination. The instrument recites that it is made under subsection 196B(2) of the VEA, and it includes the RMA’s view that there is sound medical‑scientific evidence. The date of making is 24 December 2021, with commencement on 31 January 2022. No subsequent amendments are noted. If future medical evidence emerges, the RMA may revoke and replace this instrument again, or issue an amendment adding or removing factors. Because the RMA is required under section 196C to review SoPs at least once every 10 years, but more often if the relevant Minister requests. The 2013 SoP lasted about 9 years; this one may be updated sooner. The amendment history is not part of the legislative text, but practitioners should check the Federal Register of Legislation for any amending instruments that might have been made after the publication date (24 December 2021). The instrument does not include a table of amendments, so one must rely on the regulator. It is important to note that the instrument includes two detailed drug lists that could be expanded or contracted by future instruments. For example, if the RMA later decides there is evidence for additional immune‑checkpoint inhibitors beyond nivolumab and pembrolizumab, those drugs might be added. Similarly, if the threshold for iodine excess is revised, it would require a new instrument.

The text of the instrument mentions no litigation. The user source does not include any court decisions. However, as a legislative instrument made under a specific power, it could be subject to judicial review. The Administrative Appeals Tribunal (AAT) and the Federal Court have considered challenges to RMA SoPs in the past, often on the basis that the RMA acted without evidence or that the factor is irrational. Because this SoP is recent (2022), there is likely limited litigious history specific to it. The earlier 2013 SoP may have been challenged, but those cases are not referenced in the instrument. Practitioners should be aware that the Federal Court has held that the RMA’s decisions are justiciable, but the court gives considerable deference to the RMA’s medical‑scientific judgment. Any litigation would likely arise from a claim denial where the decision‑maker applied the SoP strictly and the claimant argued that the RMA erred in its view of the medical evidence. For instance, a claimant might argue that there is sound evidence for a factor not listed (e.g. selenium deficiency) and that the RMA’s exclusion was unreasonable. But the language of the SoP (“the Repatriation Medical Authority is of the view that there is sound medical‑scientific evidence”) is a broad discretion. Litigants might also challenge the dictionary definitions, such as the pack‑year calculation or the definition of “obese”. The definition of “acute precipitating event” includes examples (e.g. abrupt cessation of thyroxine therapy) but does not limit the category; litigation could arise over whether a particular event (e.g. a mild infection) qualifies. Section 9(10) and (21) apply only to myxoedema coma, so if a claimant has myxoedema coma, the 48‑hour window for a precipitating event is strict. This could be contested if the event is a cumulative stressor rather than a single acute event. Overall, litigation history is sparse, and the instrument itself is too new to have generated significant case law.

Several features of this SoP can trap unwary claimants or practitioners. First, the distinction between “clinical onset” and “clinical worsening” is crucial. Factors 1‑10 apply only to disease that first manifested during or after service; factors 11‑22 apply only where the disease existed before or during service but was aggravated. If a veteran had Hashimoto thyroiditis diagnosed decades before service, only the worsening factors are available, and even then, the disease must have been suffered or contracted before or during service (but not arisen out of it). That means a veteran with pre‑existing Hashimoto who then serves and experiences a worsening must show that one of factors 11‑22 caused the worsening and is related to service. Factor 20 (pregnancy or within 12 months postpartum) is only available for worsening, not onset, which may affect female veterans.
Second, the time windows are fixed. Having iodine excess at any time is not enough; it must be within six months before onset (or worsening). This window is tight and may be hard to prove if the person had a high‑iodine diet decades earlier. The definition of “iodine excess” itself is two‑pronged: either an average intake >1,100 µg/day (or >900 for under‑18s) for three continuous months, or a urinary iodine concentration >300 µg/L (>500 for pregnant women). The “three continuous months” requirement is a gotcha: a brief iodine overdose (e.g. from a single contrast CT scan) would not satisfy the intake test unless that single event resulted in a urinary concentration above the threshold. The note says iodine excess may be due to foods, supplements, or medications, but many dietary sources are seasonal.
Third, the drug lists are exhaustive. If a claimant was taking a drug that could trigger autoimmune thyroiditis but is not on Specified List 1 or 2, no factor is available. For example, the lists include interferon alpha and beta, but not interferon gamma; they include dasatinib but not other tyrosine kinase inhibitors not listed. The same applies to lithium and amiodarone: they are only in List 2 (worsening) and not in List 1 (onset). A claimant who developed Hashimoto while on lithium cannot rely on it for onset.
Fourth, the smoking cessation factor (9(7) and 9(17)) is counterintuitive: it applies to those who permanently ceased smoking within five years before onset or worsening, but only if they had a prior “regular smoking habit as specified” (at least 3 pack‑years in a continuous three‑year period). This means that light smokers or former smokers who quit more than five years earlier cannot use it. Also, the direction of causation is opposite to the usual assumption: it is not smoking causing the disease, but the cessation itself that is linked to onset (perhaps due to immune system changes). Practitioners should note that the factor does not require the cessation to be related to service; rather, the fact of cessation must be connected to service (e.g. a veteran who quit while on deployment).
Fifth, the “inability to obtain appropriate clinical management” factor (9(22)) is vague and rarely successful because the decision‑maker can argue that appropriate management is available through the public health system. The claimant must show that the inability was related to service (e.g. posting to a remote area). This is a high bar.
Sixth, the instrument explicitly excludes postpartum thyroiditis from the definition of Hashimoto thyroiditis (section 7(2)(c)(iii)), yet factor 9(8) and 9(18) list postpartum thyroiditis as a separate factor. This means a person who had postpartum thyroiditis cannot claim that condition as Hashimoto; instead, postpartum thyroiditis is treated as a risk factor for Hashimoto. If the diagnosis was wrong, or the postpartum thyroiditis later evolved into Hashimoto, careful clinical staging is needed.
Finally, the “myxoedema coma” factors (9(10) and 9(21)) apply only if the Hashimoto first presents as myxoedema coma (or worsens to that). The definition of “acute precipitating event” includes many examples, but the event must be “acute” and cause a “sudden, intense physical response”. Slow‑onset infections or gradual drug withdrawal may not qualify.

Compliance is not about obeying the instrument; it is about using it correctly in claim preparation. The obligation falls on the claimant and their representatives to ensure that the hypothesis is supported by at least one of the 22 factors and that the factor is related to service. The practical steps are:

1. Determine whether the person has “relevant service” as defined. That includes operational, peacekeeping, hazardous, British nuclear test, warlike, or non‑warlike service. If not, the SoP does not apply and the claim is governed by general causation rules.
2. Obtain a definitive diagnosis of Hashimoto thyroiditis meeting the definition in section 7(2). This requires evidence of chronic autoimmune disease with lymphocytic infiltration and fibrosis (e.g. from ultrasound or biopsy), plus high anti‑TPO or anti‑Tg antibodies. The ICD‑10‑AM code must match E03.4, E03.5, or E06.3, but the clinical definition governs. Exclude Graves, postpartum, subacute, secondary hypothyroidism, and non‑autoimmune chronic thyroiditis.
3. Identify which time period is relevant: clinical onset or clinical worsening. Obtain medical evidence pinpointing when the disease first became clinically apparent (onset) and when any worsening occurred (e.g. new symptoms, increase in medication, hospitalisation). The worsening must be material.
4. Match the person’s medical and service history to the factors. For each potential factor, collect corroborative evidence:
   • Iodine excess: dietary recall, supplement labels, medication records, or urinary iodine test results from the appropriate six‑month window. If the person consumed seaweed or kelp supplements, confirm the amount and duration.
   • Drug exposure: pharmacy records and prescriptions showing one of the drugs from the relevant list, with continuous use for at least two weeks for List 2 factors. For onset (List 1), the drug must have been taken within one year before onset.
   • Radiation: oncology records showing the thyroid was in the treatment field.
   • Radioactive iodine: medical records of I‑131 treatment.
   • Hepatitis C: serology test (antibody and RNA) at the time of onset or worsening.
   • Obesity: weight records, BMI calculations over at least five years before onset/worsening.
   • Smoking cessation: evidence of prior regular smoking (3 pack‑years in a continuous three‑year period) and documentation of permanent cessation within five years before onset/worsening. The fact of cessation must be connected to service (e.g. a medical discharge).
   • Postpartum thyroiditis: medical records of thyroid dysfunction within 12 months of childbirth, and that it occurred within 10 years before onset/worsening.
   • PTSD: a formal diagnosis of PTSD per DSM or ICD criteria, with evidence of timing relative to onset/worsening.
   • Pregnancy/postpartum: for worsening only, confirm pregnancy or within 12 months postpartum.
   • Myxoedema coma: evidence of the acute precipitating event within 48 hours before the coma.
   • Inability to obtain appropriate clinical management: prove that service prevented access to treatment (e.g. remote posting, lack of specialist).
5. Relate each factor to service. That means showing that the factor itself was caused by, or occurred during, the person’s relevant service. For example, iodine excess might occur from consuming military rations; drug exposure might be from a medication prescribed for a service‑related condition; hepatitis C might be from a blood transfusion on deployment.
6. If a factor refers to a disease that has its own SoP (e.g. hepatitis C), separately satisfy that SoP’s factors.
7. Ensure that the factor exists at the time required. For instance, for smoking cessation, the cessation must be permanent and occur within five years before onset. If the person quit smoking but resumed later, the factor fails.
8. Document everything in a structured report addressed to the Repatriation Commission. Legal representatives should frame the hypothesis in terms of the specific factor number and subsection.
9. Consider the possibility of multiple factors. At least one must exist, but having more strengthens the claim.
10. If the claim relies on clinical worsening, confirm that the disease was suffered or contracted before or during service but did not arise out of service (section 10(2)). This requires careful chronology.

In summary, compliance is a fact‑gathering exercise that requires due diligence in locating medical records, military service records, and exposure data. The SoP is a checklist; failing to check one element can sink a claim.